Philippine Classifies Cuticle Tints Containing Benzalkonium Chloride with Antiseptic/Antibacterial/Disinfectant Claims as Household Remedies

Takehome: On May 29th, Philippine released a circular determining cuticle tints containing benzalkonium chloride with antiseptic/antibacterial/disinfectant claims (previously considered as cosmetics) as household remedies.

From the release date of the circular, establishments intending to manufacture, distribute, import, export, sell, offer for sale, transfer, promote and advertise cuticle tints containing benzalkonium chloride with antiseptic/antibacterial/disinfectant claims shall secure the appropriate authorizations from the Center for Drug Regulation and Research (CDRR) pursuant to existing regulations. For cuticle tints containing benzalkonium chloride with antiseptic/antibacterial/disinfectant claims which are previously notified with the Center for Cosmetic Regulation and Research (CCRR) and are already available in the Philippine market, a grace period is provided with the following conditions:

1. The grace period will start upon the signing of this circular and end on 30 June 2021 after which all valid notifications for these products shall be automatically cancelled.
2. Products that are notified with CCRR shall be allowed to be marketed as cosmetic products until the end of the grace period.
3. Products labels reflecting antiseptic/antibacterial/disinfectant claims, or a product name which includes the words “benzalkonium chloride” thereby implying the presence of an active ingredient shall be allowed to be used until its exhaustion or until the end of the grace period, whichever comes first.
4. The grace period shall be used by establishments manufacturing, distributing, importing, exporting, selling, offering for sale, transferring, promoting and advertising these products to apply for a License to Operate (LTO) as Drug Establishment and a Certificate of Product Registration (CPR) from CDRR (the Center for Drug Regulation and Research) before the end of the grace period.
5. All products found in the market after the given grace period with no authorizations (LTO and CPR) from CDRR shall be considered as without the appropriate market authorization and shall be subject to seizure, in accordance with existing laws and regulations.

The change of the classification is due to the below reasons:

• Benzalkonium chloride is allowed as an active ingredient in antiseptic/disinfectant products as well as a microbial preservative in pharmaceutical preparations to kill or inhibit the growth of microorganisms to prolong the product’s shelf life;
• The application of the products has a high probability on a broken skin rather than an intact one since the previous manual process of manicure is likely to cause trauma to intact skin;
• ASEAN Cosmetic Directive (ACD) stipulates that cosmetic products must not be presented as having properties for treating and/or preventing a disease, antimicrobial leave-on products may be considered as a cosmetic and its application on broken skin (i.e. wound cleansing) is not permitted.

In view of these reasons, cuticle tints containing benzalkonium chloride with antiseptic/antibacterial/disinfectant claims do not conform to the definition of cosmetics and are therefore classified as household remedies.

Additionally, the new classification of cuticle tints does not preclude establishments from applied them as a cosmetic product provided that ① the product is compliant with the ACD, its ingredient annexes and appendices, and ② in case the product contains benzalkonium chloride, its sole function is as a microbial preservative and no claims of antiseptic/antibacterial/disinfectant is made.